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Galactose Supplementation for the Treatment of MOGHE

Galactose Supplementation for the Treatment of Patients With Mild Malformation of Cortical Development With Oligodendroglial Hyperplasia in Epilepsy (MOGHE): a Pilot Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04833322
Acronym
GATE
Enrollment
8
Registered
2021-04-06
Start date
2021-01-15
Completion date
2021-10-01
Last updated
2021-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Epilepsy, SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation

Brief summary

Mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (MOGHE) is a new entity frequently associated with refractory epilepsy and neurodevelopmental disorders. Recently, it has been associated to SLC35A2 (Solute Carrier Family 35 Member A2) brain mosaic pathogenic variants. In addition, patients with germline SLC35A2 pathogenic variants improve with galactose supplementation. Therefore, the investigators aim to elucidate whether d-galactose as an add-on treatment might improve epilepsy and developmental outcomes in patients with MOGHE.

Interventions

DIETARY_SUPPLEMENTD-Galactose

Galactose supplementation, once per day, up to 1.5g/kg per day

Sponsors

Hospital Ruber Internacional
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Before-and-after pilot clinical trial with a single group

Eligibility

Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* MOGHE diagnosis at histopathological examination of the epilepsy surgery tissue. * Epilepsy refractoriness or ongoing epileptiform activity at EEG.

Exclusion criteria

* Allergy to galactose or supplement components.

Design outcomes

Primary

MeasureTime frameDescription
Seizure frequency6 monthsSeizure diary
Epileptiform activity at EEG6 monthsEpileptiform activity quantification (per epoch)

Secondary

MeasureTime frameDescription
Behavioral assessment6 monthsTeacher and Parent Rating Scale (SNAP-IV) and Conners Continuous Performance Test (CPT-II)
Cognitive assessment6 monthsEvaluated with Wechsler Intelligence Scale for Children (WISC-IV) and Behavior Rating Inventory of Executive Function-2 (BRIEF-2)

Countries

Spain

Contacts

Primary ContactAngel Aledo-Serrano, MD PhD
aaledo@neurologiaclinica.es0034-913875250
Backup ContactAna Rodriguez
ensayosepi@neurologiaclinica.es0034-913875250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026